extended phenytoin sodium (65162-212)

Drug Facts

Product Profile

Brand Name extended phenytoin sodium

Generic Name phenytoin sodium

Labeler amneal pharmaceuticals llc

Dosage Form CAPSULE

Routes

ORAL

Active Ingredients

phenytoin sodium 100 mg/1

Manufacturer

Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 65162-212

Product ID 65162-212_2b4f7d43-b5df-46e4-9cb9-216b70a360a0

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA040765

Listing Expiration 2026-12-31

Marketing Start 2009-12-16

Pharmacologic Class

Classes

anti-epileptic agent [epc] cytochrome p450 1a2 inducers [moa] cytochrome p450 2b6 inducers [moa] cytochrome p450 2c19 inducers [moa] cytochrome p450 2c8 inducers [moa] cytochrome p450 2c9 inducers [moa] cytochrome p450 2d6 inducers [moa] cytochrome p450 3a inducers [moa] decreased central nervous system disorganized electrical activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65162212

Hyphenated Format 65162-212

Supplemental Identifiers

RxCUI

855671

UPC

0365162212037 0365162212105

UNII

4182431BJH

Packaging Origin

Original Packager

true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name extended phenytoin sodium (source: ndc)

Generic Name phenytoin sodium (source: ndc)

Application Number ANDA040765 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

100 mg/1

source: ndc

Packaging

30 CAPSULE in 1 BOTTLE (65162-212-03)
100 CAPSULE in 1 BOTTLE (65162-212-10)
1000 CAPSULE in 1 BOTTLE (65162-212-11)
500 CAPSULE in 1 BOTTLE (65162-212-50)

source: ndc

Packages (4)

65162-212-03 30 CAPSULE in 1 BOTTLE (65162-212-03) 65162-212-10 100 CAPSULE in 1 BOTTLE (65162-212-10) 65162-212-11 1000 CAPSULE in 1 BOTTLE (65162-212-11) 65162-212-50 500 CAPSULE in 1 BOTTLE (65162-212-50)

Ingredients (1)

phenytoin sodium (100 mg/1)

Linked Drug Pages (1)

Extended Phenytoin Sodium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "2b4f7d43-b5df-46e4-9cb9-216b70a360a0", "openfda": {"upc": ["0365162212037", "0365162212105"], "unii": ["4182431BJH"], "rxcui": ["855671"], "spl_set_id": ["7e467c02-49a0-4b62-b537-430fdfa4f10e"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (65162-212-03)", "package_ndc": "65162-212-03", "marketing_start_date": "20091216"}, {"sample": false, "description": "100 CAPSULE in 1 BOTTLE (65162-212-10)", "package_ndc": "65162-212-10", "marketing_start_date": "20091216"}, {"sample": false, "description": "1000 CAPSULE in 1 BOTTLE (65162-212-11)", "package_ndc": "65162-212-11", "marketing_start_date": "20091216"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE (65162-212-50)", "package_ndc": "65162-212-50", "marketing_start_date": "20091216"}], "brand_name": "Extended Phenytoin Sodium", "product_id": "65162-212_2b4f7d43-b5df-46e4-9cb9-216b70a360a0", "dosage_form": "CAPSULE", "pharm_class": ["Anti-epileptic Agent [EPC]", "Cytochrome P450 1A2 Inducers [MoA]", "Cytochrome P450 2B6 Inducers [MoA]", "Cytochrome P450 2C19 Inducers [MoA]", "Cytochrome P450 2C8 Inducers [MoA]", "Cytochrome P450 2C9 Inducers [MoA]", "Cytochrome P450 2D6 Inducers [MoA]", "Cytochrome P450 3A Inducers [MoA]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "65162-212", "generic_name": "Phenytoin Sodium", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Extended Phenytoin Sodium", "active_ingredients": [{"name": "PHENYTOIN SODIUM", "strength": "100 mg/1"}], "application_number": "ANDA040765", "marketing_category": "ANDA", "marketing_start_date": "20091216", "listing_expiration_date": "20261231"}